A Study of Caldolor in Hospitalized Febrile Pediatric Patients

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The primary objective of this study of Caldolor administered to febrile hospitalized pediatric patients every 6 hours for 24 hours is to determine the clinical equivalence of a single dose of Caldolor compared to acetaminophen (paracetamol; APAP) for the treatment of fever as measured by the AUC Tº within the first 6 hours of treatment (as compared to a target temperature of 98.6ºF [37.0ºC]).

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Ages Eligible for Study:

6 Months to 17 Years (Child)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Be hospitalized

Be between 6 months and 17 years of age, inclusive

Have new (not chronic, within last 7 days) onset of fever, documented by temperature greater than or equal to 101.0ºF (38.3ºC) (The preferred method of temperature measurement is core. The route of temperature measurement used immediately before randomization should be used immediately before dosing and for all temperature measurements during the Treatment Period.)

Have written informed consent provided by legal parent, guardian, or authorized agent, and have same agree to abide by the study restrictions and to return for the required assessments (Where appropriate, participants of appropriate intellectual maturity should personally provide written informed assent; age of assent may be determined by Institutional Review Boards (IRBs) or Independent Ethics Committees (IECs) or be consistent with local legal requirements.)

Exclusion Criteria:

Have inadequate intravenous access

Have received antipyretic drug therapy within 8 hours before dosing

Be pregnant or nursing

Have any history of allergy or hypersensitivity to NSAIDs, aspirin, APAP, or any component of Caldolor or APAP.

Have a history of severe head trauma that required the current hospitalization, had intracranial surgery or stroke within the previous 30 days, or have any history of intracerebral arteriovenous malformation, cerebral aneurysm, or central nervous system mass lesions

Have a history of febrile convulsion or have a sibling with a history of febrile convulsion

Have a history of congenital bleeding diatheses (e.g., hemophilia) or any active clinically significant bleeding, or have underlying platelet dysfunction, including (but not limited to) idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, or congenital platelet dysfunction

Have gastrointestinal bleeding that has required medical intervention within the previous 6 weeks, unless definitive surgery has been performed

Have platelet count less than 30,000/mm3

Be receiving full dose anticoagulation therapy (Prophylaxis with subcutaneous heparin is acceptable.)

Have fever secondary to blood or drug reaction

Have an expected life span of less than 14 days because of imminent withdrawal of life support or severity of illness

Be receiving ongoing or imminent treatment with corticosteroids

Have neurogenic fever

Be on dialysis, have oliguria or calculated creatinine clearance of less than 70 mL/min (calculated using the Schwartz formula), have impaired renal function, be receiving nephrotoxic drugs, or be expected to be unable to tolerate the extra fluid required for administration of CTM

Have had major surgery within the past 12 hours, unless adequate hemostasis has been achieved

Have received another investigational drug within the past 30 days

Be otherwise unsuitable for the study, in the opinion of the Investigator